Inhaler for multiple dosed administration of a pharmacological dry powder

ABSTRACT

An inhaler for multiple dosed administration of a pharmacological dry powder consists externally of a housing ( 100,150 ) and of a protective cap ( 950 ) which can be removed from a special mouthpiece ( 900 ) fitted on the housing. Arranged on the inside there are a slide rail ( 200 ), a dosing slide ( 300 ), a shutter ( 400 ), a carriage ( 500 ), a funnel arrangement ( 600 ), a counter device ( 700 ), a valve shield ( 800 ) and a valve guide ( 850 ). Removal of the protective cap ( 950 ) initiates the dosing, with a dose received in the dosing cavity ( 302 ) being transported to the mouth-piece ( 900 ) by means of the dosing slide ( 300 ). Only upon application of a defined minimum intensity of inhalation is the shutter ( 400 ) moved by the suctioned valve shield ( 800 ), as a result of which the dose is released for inhalation. Completed with an electronic module and a controllable nozzle, all inhalation-relevant data can be recorded and the flow conditions regulated.

AREA OF APPLICATION OF THE INVENTION

The invention relates to a dry powder inhaler with dosed administrationof a medical preparation upon inhalation by the patient. The drypowder—in loose form or pre-dosed units for dispensing—is contained in amedicament reservoir. The invention concerns the generic type ofinhalers in which, upon activation, a defined dose is first of allintroduced from the internal medicament reservoir into the inhalationchannel by means of a portioning mechanism, and from there the patientdraws this defined dose into his airways via a mouthpiece, in a flow ofair generated by aspiration.

Inhalation is a proven method of depositing medicinal agents in thelungs or delivering them to the blood. Thus, in addition to the devicesfor atomizing or nebulizing of liquids, for example by means of air,compressors, ultrasound, liquefied propellant gases (fluorohydrocarbons,fluorochlorinated hydrocarbons), inhalers for pulverulent preparationwith dosed portioning were also developed for the purpose of inhalation.

A defining feature of inhalers is that the active substance particles ofthe medicament are deposited, by inhalation, in a defined dose andparticle size (about 1-6 μm) either in the central or peripheral lungcompartments (topical treatment) or as very small particles by means ofabsorption in the alveolar region into the blood stream of the patient(systemic treatment).

However, micronized particles with the diameter in question here haveextremely poor flow characteristics. This problem is solved by a numberof conventional methods. Thus, powder mixtures are produced with acarrier which generally has a greater particle diameter than the activesubstance, with the active substance particles depositing themselves onthe carrier surface. On the other hand, in the manufacture of softpellets, a large number of active substance particles are massedtogether to form respectively larger particles, the pellets. Under theeffect of force, the pellets split up again into the individual, smalleractive substance particles. During inhalation it should be possible withthe inhaler to detach the active substance particles from the carrier orto break the pellets up again into small particles. Simple swallowing ofthe medicament is completely undesirable. For this reason, specialfunctional demands are imposed on inhalers in principle.

PRIOR ART

EP-A-0 404 454 and EP-A-0 558 879 disclose inhalers for single use. Suchdesigns are appropriate only for special applications, since on the onehand the patient has no control over the correct use, i.e. the optimuminhalation, and on the other hand a new inhaler has to be used for eachinhalation, which is costly, inconvenient and not environmentallyfriendly.

Thus, inhalers with a dry powder as medicament were developed also formultiple use. WO 93/03782 discloses an inhaler with a medicamentreservoir and a dosing mechanism, by means of which the medicament isconveyed in doses from the storage container into the inhalation channeland can be sucked from there with the flow of air generated by thepatient. This inhaler does not yet satisfy all the requirements. Theexact and prescribed use can still not necessarily be sufficientlyguaranteed. The dosing accuracy has to be increased; humidity too easilypenetrates into the inhaler, the deagglomeration and atomization have tobe improved, and keeping the inhaler clean is complicated.

U.S. Pat. No. 5,239,992 discloses a further inhaler in which a dosingcavity is present in a longitudinally displaceable piston rod and thisdosing cavity, first positioned under the medicament reservoir, receivesa dose of medicament. The patient has to inhale counter to the force ofa spring, so that the piston rod moves and the ready-to-use dose can besucked by the patient through suction openings in the guide channel ofthe piston rod. In principle, this inhaler too exhibits theabovementioned inadequacies.

WO 94/05359 describes an inhaler for multiple dosed administration of apharmacological dry powder which is contained within a medicamentreservoir provided inside the housing. On the inhaler a mouthpiece isjoined which is closed outside inhalations by a folding down protectivecap. The inhaler further has inside a horizontally movable carriage witha dosing depression. If the protective cap is closed the dosingdepression is positioned underneath the funnel-shaped outlet of themedicament reservoir, so that dry powder by its gravity should flow intothe dosing depression until it is full if the inhaler is in a verticalposition. One filling of the depression represents one dose.

After a preceding inhalation a spring arranged above a bellows is tensedby closing the protective cap. The bellows is placed on the medicamentreservoir, an air permeable membrane is provided as a separating wall.During opening the protective cap, the locking of the tensed spring isreleased, so an air pressure pulse acts upon the medicament reservoir.This air pressure pulse ought to guarantee that in each case the dosingdepression is properly filled with dry powder. The carriage is moved byfurther opening of the protective cap, so the dosing depression ispositioned within a suction channel. With the inhalation the medicamentdose is sucked out from the dosing depression through the mouthpiece.The mouthpiece has at one side a flange for joining to the housing ofthe inhaler and has at the other side a suction pipe outwardlytrumped-like opening. A flow channel flows tangentially into the flangewhich channel is connected with the suction channel, where themedicament dose is available in readiness for inhalation. At the flange,tangentially arranged air openings are provided for the purpose ofturbulence of the medicament containing air stream sucked into themouthpiece.

The spring above the bellows again tenses by closing the protection capand the carriage goes back into its starting position, so the dosingdepression is again positioned underneath the funnel-like outlet of themedicament reservoir and the next inhalation cycle can start.

The previously described inhaler and its pertinent mouthpiece shows thefollowing essential disadvantages:

Independent of the intensity of the inhalation, the medicament from thedosing depression can be sucked out too low such that the medicamentparticles only insufficiently arrive at their intended position withinthe patient's respiratory ducts and/or actually only a part of the doseavailable is sucked out. Thus the patient has no control as to whetherthe inhalation has been actually done or correctly completed.

After opening the protective cap and during inhalation, the inhaler hasto be positioned vertically, otherwise the dry powder can flow back fromthe dosing depression into the medicament reservoir or come into thesuction channel situated above the dosing depression and deposit thereas a loss. A construction feature is missing which obligates or requiresthe patient to apply the inhaler in the right functional position, i.e.,not in an angled or oblique position in which the medicament does notflow or flows insufficiently into the channel inside the inhaler fromwhich the patient inhales the powder.

At lease a part of the dry powder of the unused dose can come into thesuction channel if the inhalation is incompletely finished or not doneat all and the inhaler is not held strictly vertically. By the nextinhalation cycle it is metered again, and therefore inaccuracies of thedosage can emerge. Based on the construction, double dosages or dosagesunder the limit can happen.

The extending bellows sucks in a larger amount of external air with eachclosing of the protective cap, thereby permitting moisture to enter themedicament reservoir. This is disadvantageous for the flowability andthe accuracy of metering of the dry powder as known from the literatureand the practice.

A further construction feature is missing which guarantees that the last5 to 10 nominal doses in the declared measure (weight and volume) can bedelivered in order to solve the tail-off-problem known of inhalers witha multi dosage reservoir.

The mouthpiece has at its flange a tangentially discharging channel andopenings for acceleration and turbulence of the airstream generated bythe patient. This corresponds with the cycle principle as used for along time for the dry powder inhalers available on the market (e.g.SPINHALER®, CYCLONHALER®).

The unit for creating turbulence and the mouthpiece can be cleaned anddried internally relatively poorly which under certain circumstances cancause microbiological problems.

OBJECT OF THE INVENTION

Thus, in summary, it may be stated that none of the inhalers known todate can be regarded as optimal. The present invention is thereforebased on the problem of producing an inhaler whose functionalcharacteristics are extensively improved. The design construction isintended to conclusively guarantee the prescribed inhalation positionand inhalation intensity. In the inhaler there must be a suitableregistration and function covering a properly completed inhalation, anomitted inhalation, or an incomplete inhalation; in any event, amultiple dosage is to be prevented. It is necessary to improve thedosing accuracy upon preparation of the individual doses from themedicament reservoir, and the deagglomeration and atomization of themedicament during inhalation. The protection against humidity is to bemade more effective and the cleaning of the inhaler should be madeeasier. It must be ensured that a mouthpiece which has been removed forcleaning is fitted in place again by the patient. The mouthpiece oughtto be used as well as in connection with the inhaler to be created aswith other inhalers of the present type. Finally, it must be possiblefor the inhaler to be manufactured efficiently as a mass-producedarticle and at the same time satisfy all the regulations laid down indrugs legislation.

SUMMARY OF THE INVENTION

The inhaler is used for the multiple dosed administration of apharmacological dry powder; it consists externally of a housing and of aprotective cap which can be removed from a special mouthpiece fitted onthe housing. Arranged on the inside there are a slide rail, a dosingslide, a shutter, a carriage, a funnel arrangement, a counter device, avalve shield and a valve guide. Removal of the protective cap initiatesthe dosing, with the dose received in the dosing cavity beingtransported to the mouthpiece by means of the dosing slide. Only uponapplication of a defined minimum intensity of inhalation is the shuttermoved by the suctioned valve plate, as a result of which the dose isreleased for inhalation. Only after a properly completed inhalation canthe dosing slide be returned with its dosing cavity under the funneloutlet for the purpose of preparing for renewed filling.

In the inside of the inhaler there are blocking means which come intoaction as soon as the inhaler, upon removal of the protective cap, issituated in a horizontal and/or axial inclined position going beyond adefined extent. The correct dosing and use position of the inhaler areguaranteed in this way. For the patient's safety, optional blockingmeans can be fitted which prevent any possibility of the protective capof the inhaler being closed when the mouthpiece is missing. This ensuresthat after the mouthpiece has been removed, it is not possible to omitreplacing it.

In the mouthpiece, which can be detached from the housing of the rest ofthe inhaler, there is a labyrinthine atomizing path for powderdeagglomeration, in which path there is at least one barrier. For thepurpose of reducing the powder flow rate and depositing relativelycoarse particles ineffective for inhalation, the atomizing pathcomprises, upstream of the channel outlet, a channel section which is ofincreased volume and which deflects the powder aerosol flowing through.The multi-component mouthpiece can preferably be arranged on the inhalerhousing by means of a plug connection and can be opened out afterdetachment from the housing, the mouthpiece parts being connected to oneanother via an integral film hinge. The mouthpiece according to theinvention is preferably intended for use with the inhaler according tothe invention, but it is also suitable for use in connection with otherinhalers of the same type.

In the inhaler there are means which contribute to the regular flow ofthe pharmacological dry powder when the protective cap is removed. Thegenerated vibrations preferably only exert an effect while the dosingcavity is located under the funnel outlet. These means areadvantageously complementary grate sections which are located oncomponents moved relative to one another.

The inhaler can be supplemented with an electronic module and acontrollable nozzle so that all data relevant to inhalation can berecorded and the flow conditions regulated. Completion of a correctinhalation, or an incomplete inhalation, can be indicated by an acousticand/or optical signal.

BRIEF DESCRIPTION OF THE ATTACHED DRAWINGS

FIG. 1A inhaler, side view; closed state (starting position→situationA1);

FIG. 1B inhaler, rear view;

FIG. 1C inhaler, front view;

FIG. 1D inhaler, plan view;

FIG. 1E inhaler: protective cap pulled out (intermediateposition→situation A2);

FIG. 1F inhaler: protective cap swung down fully (ready forinhalation→situation A4; inhalation omitted→situation A5; inhalationincomplete→situation A6; inhalation complete→Situation A7);

FIG. 2A protective cap, perspective view;

FIG. 2B protective cap, plan view;

FIG. 2C protective cap, side view;

FIG. 2D view into the protective cap;

FIG. 3A lower part of housing, perspective view;

FIG. 3B lower part of housing, plan view;

FIG. 3C lower part of housing, side view;

FIG. 3D lower part of housing, cross-sectional view;

FIG. 3E lower part of housing, perspective view with blocking hooks andballs;

FIG. 3F lower part of housing according to FIG. 3E, plan view;

FIG. 4 upper part of housing, perspective view;

FIG. 5A mouthpiece, perspective view of the base plate;

FIG. 5B mouthpiece, side perspective;

FIG. 5C one half of mouthpiece, external view;

FIG. 5D one half of mouthpiece, internal perspective;

FIG. 5E mouthpiece opened out, internal perspective;

FIG. 6A slide rail, perspective view from below;

FIG. 6B slide rail, side perspective;

FIG. 7A carriage, perspective view from below;

FIG. 7B carriage, perspective view from above, laterally, from thefront;

FIG. 7C carriage, perspective view from above, front;

FIG. 7D carriage, perspective view from above, rear;

FIG. 8A dosing slide, perspective view from above;

FIG. 8B dosing slide, perspective view from above, rear;

FIG. 8C dosing slide, perspective view from below;

FIG. 9A shutter, perspective view from above;

FIG. 9B shutter, perspective view from below;

FIG. 10A valve shield, perspective view;

FIG. 10B valve shield, side perspective;

FIG. 11A valve guide, inner perspective;

FIG. 11B valve guide, outer perspective;

FIG. 12A funnel, perspective view from above;

FIG. 12B funnel, perspective view from below;

FIG. 13A funnel holder, perspective view from above;

FIG. 13B funnel holder, side perspective;

FIG. 13C funnel holder, perspective view from below;

FIG. 14A funnel lid, perspective view from above;

FIG. 14B funnel lid, perspective view from below;

FIG. 14C funnel lid with semi-permeable membrane;

FIG. 15A funnel holder, funnel and funnel lid, side perspective;

FIG. 15B funnel holder and fitted funnel, perspective view from above;

FIG. 16A counter, perspective view of the units wheel;

FIG. 16B counter, perspective view of the hundreds wheel;

FIG. 16C counter, units wheel, outer perspective;

FIG. 16D counter, units wheel, inner perspective;

FIG. 16E counter, tens wheel, outer perspective;

FIG. 16F counter, tens wheel, inner perspective;

FIG. 16G counter, hundreds wheel, inner perspective;

FIG. 16H counter, hundreds wheel, outer perspective;

FIG. 16I counter body, inner perspective;

FIG. 16J counter body, outer perspective;

FIG. 16K counter, cover plate, outer perspective;

FIG. 16L counter, cover plate, inner perspective;

FIG. 16M counter, drive wheel, outer perspective;

FIG. 16N counter, drive wheel, inner perspective;

FIG. 16O engagement of the dosing slide on the counter, units wheel;

FIG. 17A blocking hook, plan view;

FIG. 17B blocking hook, perspective view from right;

FIG. 17C blocking hook, perspective view from left;

FIG. 18A inhaler, horizontal longitudinal section according to FIG. 1Aon line A—A;

FIG. 18B inhaler, vertical longitudinal section according to FIG. 1D onlin B—B;

FIG. 18C inhaler, vertical transverse section according to FIG. 1D online C—C;

FIGS. 19A to 19D functioning principle of the release of the shutter;

FIG. 19A side wings of the carriage with aperture and cam;

FIG. 19B closed inhaler according to FIGS. 1A and 18A (situation A1);

FIG. 19C shutter close to release, with the protective cap not swungdown fully (situation A3);

FIG. 19D shutter released, with protective cap swung down fully inaccordance with FIG. 1F (situation A4);

FIGS. 20A to 20F functioning principle of the inhaler

FIG. 20A inhaler closed in accordance with FIGS. 1A, 18A and 19B(starting position→situation A1);

FIG. 20B inhaler open in accordance with FIGS. 1F and 19D (ready forinhalation→situation A4);

FIG. 20C closing the inhaler (inhalation omitted→situation A5);

FIG. 20D closing the inhaler (inhalation incomplete→situation A6);

FIG. 20E inhaler closed (after incomplete inhalation→situation A8);

FIG. 20F inhaler closed (after completed inhalation→situation A7);

FIGS. 21A to 21C functioning principle of the blocking hooks:

FIG. 21A blocking hooks fitted (starting position→situation B1);

FIG. 21B protective cap blocked when mouthpiece missing (incorrectposition→situation B2);

FIG. 21C pivotable protective cap, with mouthpiece fitted (desiredposition→situation B3);

FIGS. 22A and 22B functioning principle of the blocking of the inhalerat an inclined position:

FIG. 22A side position of the blocking balls on incorrect positioning ofthe inhaler;

FIG. 22B blocked inhaler;

FIGS. 23A to 23G successive construction of inhaler, perspective views;

FIG. 23A lower part of housing with valve shield, valve guide and onemouthpiece half;

FIG. 23B representation in accordance with FIG. 23A, with slide rail andcarriage added;

FIG. 23C representation according to FIG. 23B, with dosing slide added;

FIG. 23D representation in accordance with FIG. 23C, with shutter added;

FIG. 23E representation in accordance with FIG. 23D, with protective capadded, without lower part of housing;

FIG. 23F representation in accordance with FIG. 23E, with funnel holder,funnel, funnel lid and counter added; and

FIG. 23G representation in accordance with FIG. 23F, from the rear side.

EXEMPLARY EMBODIMENT

In the text which follows, the inhaler according to the invention willbe described in greater detail in terms of its construction, as well asits function, with reference to the attached drawings, and possiblemodifications are mentioned by way of conclusion.

The following statement applies to the whole of the descriptionfollowing. If, for the purpose of clarity of the drawing, referencenumbers are included in a figure but are not explained in the directlyrelevant text of the description, then reference is made to theirmention in preceding figure descriptions. In the interest ofintelligibility, the repeated designation of components in succeedingfigures is for the most part omitted if it is clear from the drawingsthat the components concerned are “recurring” components.

FIGS. 1A to 1D

Externally, the inhaler according to the invention is made up of thelower part 100 of the housing, the upper part 150 of the housing, andthe protective cap 950. The lower part 100 of the housing and the upperpart 150 of the housing have an elongate, semi-monocoque configuration.The upper part 150 has, on its top side, a fairly large opening 151 forreceiving a funnel lid 680, and a window 152 through which the status ofthe counter can be read off. The lower part 100 of the housing and theupper part 150 of the housing are joined to one another such that ahousing is obtained which is in principle closed. Grip contours 951 areprovided on the outside of the protective cap 950 to permit bettergripping. Grip contours, preferably designed as grip dimples 113, arealso arranged on both sides of the housing, in this case extending overthe lower part 100 of the housing and the upper part 150 of the housing.

On the top of the protective cap 950, towards the outer edge, there isan elongate recess, by which means a clearance 968 is created togetherwith the adjoining upper part 150 of the housing. By looking into thisclearance 968 it is possible to ascertain if the mouthpiece is fittedand the clearance 968 is thus filled, or if the mouthpiece is missingand the clearance 968 is consequently open. Opposite the protective cap950—on the rear part of the inhaler—the perforated base 854 of the valveguide enclosed by the lower part 100 of the housing and upper part 150of the housing can be seen.

In the closed state shown here, the starting position—subsequentlyreferred to as Situation A1—the protective cap 950 is fitted flush withthe lower part 100 of the housing and the upper part 150 of the housing.Thus, the medical preparation stored in the inhaler is protected quasihermetically from external humidity.

FIG. 1E

The inhaler has to be opened before use; to do this, the protective cap950 is first of all pulled out in the axial direction. The line alongwhich the protective cap 950 is pulled out is limited by a pair of sidearms 960 which are fixed on the protective cap 950 and engage in alongitudinally displaceable manner in the inside of the inhaler. Withthe protective cap 950 pulled out this far, the mouthpiece 900 isalready partly visible and is attached to the lower part 100 of thehousing and the upper part 150 of the housing at the front and isenclosed on both sides by the side arms 960. As will be explained later,this step is associated with a temporary vibration for exact dosing ofthe medicament from the powder reservoir. This intermediate position,with the protective cap 950 pulled out, is hereinafter referred to asSituation A2.

FIG. 1F

In order to allow the patient access to the mouthpiece 900, i.e. topermit inhalation, the protective cap 950 suspended on the side arms 960has to be swung down in a further maneuver. The mouthpiece 900 with themouth tube 920 protruding from the base plate 910 is now fully visible.The channel outlet 922 through which the patient inhales the medicamentis situated on the end face 921 of the mouth tube 920.

In this position, with the protective cap pulled out and swung fullydown—subsequently referred to as Situation A4—the inhaler itself isprepared for inhalation. The dose of medicament which has been madeready is in a loosened state. It should be understood that theprotective cap 950 can only be swung down when it has first been pulledout to the limit. The dimensioning of the mouthpiece 900, the length ofthe side arms 960, and the sole possibility of swinging the protectivecap 950 downwards, cause the patient by necessity to place the inhalerin the correct position. If the inhaler were used upside down in error,the patient would notice this immediately since his nose would hitagainst the protective cap 950 and he would thus barely be able to applythe mouthpiece 900.

Situation A3 characterizes the state in which the protective cap 950 isin its swing movement and has not yet reached its lowest position.

FIGS. 2A to 2D

The protective cap 950 consists of the two aforementioned side arms 960and the actual cap 952. The clearances 968, which provide space for thebase plate 910 of the mouthpiece 900, are arranged on that edge of thecap 952 facing towards the mouthpiece 900, centrally on the top side andbottom side.

The two side arms 960 each extend laterally into the cap 952. At thefront part, which engages in the inhaler, the side arms 960 have aspecial construction symmetrical to one another. Each side arm 960 has asquare, rounded aperture 961, a pin 962 lying below the rounded aperture961 and directed inwards, a recess 963 incorporated from the undersideof the side arm and having a cut edge 964, as well as forward bevels969. Between the aperture 961 and the cut edge 964 in each side arm 960there is a further rectangular aperture 970. Offset above this aperture970 there is an outwardly directed dimple 971. The same type of dimple972 is arranged in the lower area of the side arm 960 near the entry tothe cap 952.

FIGS. 3A to 3D

The lower part 100 of the housing has, on both sides, a plurality ofstop cams 101 spaced apart from one another and projecting above theside wall. To the rear, the lower part 100 of the housing isstrengthened at the end, so that a semicircular bearing ring 102 isobtained. A double wall 103, likewise semicircular and with a radialreceiving groove 104, is provided on the base at a distance from thebearing ring 102. Running centrally between the double wall 103 is araised, axial connecting web 115.

Arranged on the base are two parallel bars 106 which extend from thefront side 105 and which each have an outwardly facing indentation 116in the rear area and an obliquely cut aperture 117 in the front area.Together with two columns 118 lying opposite one another at a distance,and a rail 119 extending along with wall of the lower part 100 of thehousing, the indentation 116 delimits a depression-like ball socket 108.There is also an indentation 120 provided in the rail 119, and theindentations 116, 120 of the identical form lie opposite one another.The columns 118 have points 121 which are directed towards one anotherand which at their deepest point are located in the ball socket 108. Oneach of the rear columns 118 there is an inwardly pointing hook 122. Araised plug 123 is in each case arranged in front of the front pillars118, facing towards the front side 105. At the front side 105, tworeceiving notches 109 are incorporated, as well as two axially extendinglongitudinal slots 110 in the base—near each housing wall. A safety cam125 sits to the side at the entrance of each longitudinal slot 110.Between the two bars 106 and the front side 105 there are two U-shapeddepressions 124.

FIGS. 3E and 3F

In the completed state, a blocking ball 130 lies in each ball socket 108and, with the inhaler in the correct position, this blocking ball 130 islocated at the deepest point between the points 121 of the columns 118.When the inhaler is in an excessively horizontal or axial inclinedposition, the blocking balls 130 roll into the indentation 116 of thebar 106 or into the indentation 120 of the rail 119 and effect ablocking of the inhaler, as described in FIGS. 22A and 22B.

To ensure that the removed mouthpiece 900 is put back in place beforethe inhaler is closed, blocking hooks 140 are optionally fitted on theplugs 123. A blocking hook 140 consists of a spring arm 142 and a lever143 with a laterally protruding blocking tooth 144 and the catch 145pointing to the front side 105. The spring arm 142 of the blocking hook140 passes through the aperture 117, while the lever 143 is pressedoutwards by the tensioning of the spring arm 142, so that it is blockingtooth 144 protrudes into the course of the longitudinal slot 110 where,in the completed state, the respective side arm 960 of the protectivecap 900 sits. The function of the blocking hooks 140 is described indetail in FIGS. 21A to 21C.

FIG. 4

Complementing the stop cams 101, the upper part 150 of the housing hasplug holes 153 on its side walls. Analogously to the lower part 100 ofthe housing, the upper part 150 of the housing also has a semicircularbearing ring 154 to the rear, as well as a double wall 155 with areceiving groove 156. The half bearing rings 102 and 154, respectively,and the receiving grooves 104 and 156 combine to form full circles.

On the side walls, mounted ahead of the receiving groove 156, there arein each case a support cam 158 and a higher overspring rib 157. Thesupport cam 158 and the overspring rib 157 project towards the center ofthe upper part 150 of the housing and have a common point of origin onthe side wall. Adjacent to the window 152, two parallel supports 159spaced apart from one another are arranged on the interior of the upperpart 150. In the interior of the upper part 150 there is also the recess151 for the funnel which is to be fitted. On both sides of this recess151, towards the side walls, a limit cam 164 in each case stands outfrom the interior of the upper part 150.

Corresponding to the longitudinal slots 110 in the lower part 100 of thehousing, there are also two slots 161 in the front side 160 of the upperpart 150 of the housing. In the front side 160 there is additionally acentral receiving notch 162, and two elastic clamping prongs 163 extendfrom the front side 160 in the direction of the mouthpiece 900. Across-piece 165 stretches between the front side 160 and the base of theclamping prongs 163, and adjacent to the receiving notch 162. To therear of the front side 160, the clamping prongs 163 merge into avertical U-profile 166, the vertical grooves 167 of the U-profiles 166internally adjoining the front side 160 and facing one another.

FIGS. 5A to 5E

The mouthpiece 900 consisting of the base plate 910 and the mouth tube920 is advantageously made of two halves which are joined together, forexample, by an integral film hinge 923 provided on the end face 921. Onthe base plate 910, facing the inhaler, there is a full connector plug911 at the bottom of each half, and a half-cam 912 at the top, whichcomplements the adjacent half-cam 912. Each connector plug 911 has atits front free end, in the lower area, a recess 930 with an inwardlydirected bevel 931.

Incorporated underneath the two half-cams 912 is an engagement opening913 which extends as a shaft 932 right into the mouth tube 920. Deeperin the shaft 932, a recessed groove 933 is present in each caselaterally in the wall of the mouth tube 920. The channel inlet 914 forthe atomizer path 924 of the mouth tube 920 lies below the engagementopening 913. The channel inlet 914 is connected to the channel outlet922 via the atomizer path 924. A horizontal ramp 935, complementing thesecond half of the mouthpiece, is in each case arranged on the baseplate 910 under the channel inlet 914.

Inside the atomizer path 924, behind the channel inlet 914, there are aplurality of baffles 925 which protrude into the atomizer path 924 forimpacting the medicament-containing air stream and causing it to swirl,so that the atomizer path 924 acquires a course which is rich in curves.Nearer the channel outlet 922, the powder aerosol flowing through entersvia an S-curve into an enlarged channel section 928 and is heredeflected to the channel outlet 922. The purpose of the specialconfiguration of the atomizer path is to deagglomerate the powder and toreduce the flow rate of the powder so as to deposit coarser particleswhich are ineffective for inhalation. At the same time, the impacting ofparticles of active substance in the pharynx of the patient is thusprevented. The mouth tube 920 is flattened off horizontally, at least inthe area of the end face 921, so that the patient is induced to employthe correct positioning of the inhaler during use.

FIGS. 6A and 6B

The slide rail 200 has two longitudinal grooves 202 which extendlaterally from the end face 201 and parallel to one another, and whichreach to approximately halfway along the slide rail 200. In acontinuation of the end face 201, two feet 204 spaced apart from oneanother extend downwards from the bottom of the slide rail 200. At thetop, the slide rail 200 has a ledge-like roof part 210 which protrudesover the end face 201 in the matter of a projecting roof. At theopposite end from the end face 201, the slide rail 200 ends in a slopingsurface 205 which merges ramp-like with the top surface of the sliderail 200, the roof part 210 ending in front of the sloping surface 205.

FIGS. 7A to 7D

The carriage 500 has two wings 503, 523 rising laterally and beginningon the front side 501, with an outwardly directed cam 504 being in eachcase arranged thereon. The cam 504 is wider in the horizontal than inthe vertical, so that an approximately oval shape is obtained. Anarcuate aperture 505 is incorporated in the wings 503, 523 and runsround the cam 504 from below in a part circle. At its rear side 507, thecarriage 500 has two laterally rising struts 508, 510, the strut 508having a horizontal shoulder 509. Two pull cams 512 rise from thecarriage base 511, while to the rear side 507 the carriage base 511continues in the form of two elastic spring tongues 513 which end asspring wedges 514 and can be deflected out to the sides. Between the twospring tongues 513, a longitudinal groove 520 extends centrally throughthe carriage base 511. A pull catch 521 is present on the front side 501between the groove 520 and each of the wings 503, 523. Towards the frontside 501, the wing 523 has a grate section 515 on the inside.

Underneath the groove 520, the carriage 500 has two runners 522 on itsunderside. Also on the underside of the carriage, towards the outside asviewed from the runners 522, there are two pairs of impact ridges 524which correspond to the two ball sockets 108 in the lower part 100 ofthe housing. The two impact ridges 524 on one pair are arranged at adistance from one another. A stepped bulge 516 is positioned ahead ofeach pair of impact ridges 524, in the direction of the front side 501.

FIGS. 8A to 8C

Near its front edge 301, the tongue-like dosing slide 300 has athrough-bore, the dosing cavity 302. Starting from the front edge 301,the dosing slide 300 extends firstly as a narrow tongue tip 303 and thenwidens to the rear part 304. A spring leaf 305, from which a cam 306rises perpendicularly, is arranged on the outside flank of the rear part304.

On the underside, the dosing slide 300 has flank ridges 307 which beginimmediately behind the dosing cavity 302 and there form limit stop edges308. The dosing cavity 302 is surrounded by a radial sealing rim 320 onthe underside. Near the transition to the rear part 304, there are twodownwardly extending transverse cams 309. On the rear edge 310 of thedosing slide 300 there are two downwardly directed, profiled catches321.

FIGS. 9A and 9B

The shutter 400 has the function of releasing the medicament made readyin the dosing cavity 302 only when there is a suitably forcefulinhalation. At the very front, the shutter 400 has a sleeve-like closurepart 401 with the through-opening 402. Behind the closure part 401 thereare outer, vertical side ridges 403, beginning with a limit stop 404. Anoutwardly directed and ramp-shaped wing 405 is arranged on each sideridge 403. In the direction of the rear part 406, the wing 405 isfollowed by a side bracket 407. At the bottom, on the rear edge 408, theshutter 400 also has an outwardly directed carrier 409. On the bottom,in the area of the wings 405, two base plates 410 extend towards oneanother, leaving a through-gap 411. Towards the rear edge 408, the endof the rear part 406 is provided with a cover 420 which at the topstretches across the two parallel side ridges 403 and beginsapproximately in the area of the side brackets 407. In the cover 420there is a rounded-off groove 421 which extends along the middle andwhich is open to the center of the shutter 400.

FIGS. 10A and 10B

The valve shield 800 has the function of inducing the patient togenerate a defined minimum suction for a correct inhalation. The valveshield 800 consists of a cylindrical capsule 810 and a plurality of armsattached thereto and having different tasks. The capsule 810 has aflange-like collar 811 surrounding the opening and protruding outwards.The bottom 812 of the capsule 810 is convexly curved outwards and has alarge number of raised stubs 813 on the outside.

The further elements of the valve shield 800 are attachedperpendicularly onto the collar 811 and extend in the axial direction.On the collar 811 there is firstly a pair of long tentacles 820 whichlie opposite one another and which have carriers 821 at their veryfront. Before the tentacles 820 there are two shorter spring arms 822with outwardly directed wedge profiles 823 at their tips. Behind thetentacles 820 there are two further spring arms 825 with outwardlydirected hooks 826. Between these spring arms 825 there are two shortlocking teeth 824 standing close to one another.

FIGS. 11A and 11B

The capsule-shaped valve guide 850, when fitted into the lower part 100of the housing and the upper part 150 of the housing, serves to receivethe valve shield 800, i.e. its capsule 810. To this extent the valveguide 850 has the function of a slide bearing. Complementing the collar811 of the valve shield 800, the valve guide 850 has an external limitstop flange 851. Slide ribs 852 in the inside of the valve guide 850have the purpose of reducing the friction as the valve shield 800travels out. The perforated bottom 854 has numerous holes 855, so thatthe stubs 813 of the valve shield 800 find space therein. At the top andbottom of the limit stop flange 851 there are two diametrically oppositenotches 856. The holes 855 and the stubs 813 make it possible to designthe inhaler virtually closed at the rear and thus to prevent thepenetration of dirt particles and the inadvertent displacement of thevalve shield 800.

FIGS. 12A and 12B

The funnel 690 is intended for fitting into the funnel holder 601 (seeFIGS. 13A, 13B). The funnel bottom 691 is designed sloping obliquelytowards the outlet 692, so that the medicament powder flows in afavorable manner. The outlet 692 is surrounded on the outside by asealing element 694. On the outside, the funnel 690 has retainer cams695 projecting upwards on two opposite sides, as well as a centrallypositioned fixing nose 696 which sits on the oblique funnel bottombetween the retainer cams 695.

FIGS. 13A and 13B

The box-shaped funnel holder 601 has, on the underside, the holderbottom 603, the front wall 611, the rear wall 612, and the twohalf-height side walls 613, 614 lying between the front and rear walls611, 612. Located in the holder bottom 603 are the funnel outlet 608 andan elongate groove 615. At the very bottom, a sealing member 622surrounds the funnel outlet 608, so that it is possible to prevent theentry of humidity and the escape of powder from the funnel 690 onto thesliding surfaces of the dosing slide 300.

Arranged perpendicularly on the front wall 611 are two angled rails 616,and at the top of the rear wall 612 there is a support edge 602, fromwhich a spring arm 617 in each case extends along the two side walls613, 614. A groove 618 facing the respective side wall 613, 614 isprovided in each of the spring arms 617. The side walls 613, 614 eachhave a downwardly open notch 619 approximately at their center on thelower edge. A grate section 621 is provided on one side wall 613 nearthe rear wall 612. Two elastic lamellae 605 are connected to the rearwall 612 and extend along the outer flanks of the holder bottom 603. Thelamellae 605 have vertically movable ends with downwardly projectingblocking cams 609.

FIGS. 14A to 14C

The funnel lid 680 serves to close the funnel 690. On the underside ofthe funnel lid 680 there is a chamber 681 which is closed by asemi-permeable membrane 682. The chamber 681 is intended to receive amoisture-attracting desiccant powder and the moisture can diffusethrough the semi-permeable membrane 682.

FIGS. 15A and 15B

When the funnel arrangement is in its completed state, the funnel 690 isfitted into the funnel holder 601, and the funnel 690 is closed by thefunnel lid 680. However, the sequence of assembly of the inhaler neednot include the prior completion of the funnel arrangement.

FIGS. 16A and 16B

The complete counter 700 consists of the units wheel 701, the tens wheel780, the hundreds wheel 720, the counter body 740, the counter coverplate 760, and two identical drive wheels, which are not shown here. Thepurpose of the counter 700 is to register the number of doses used ordoses still available and to indicate to the patient the inhalationwhich has just taken place, as long as it was performed correctly.Numbers and, if appropriate, a color marking are provided on thecircumference of the counter wheels 701, 780 and 720 fixed on the axle741 of the counter body 740. The current status of the counter isdisplayed under a lens 742 which sits in the window 152 of the upperpart 150 of the housing. The lens 742 is connected to the counter body740.

FIGS. 16C and 16D

The units wheel 701 has ten radially distributed cams 703 on its outersurface 702.

FIGS. 16E and 16F

The tens wheel 780 with its inner toothed ring 781 is itself of aconventional construction.

FIGS. 16G and 16H

The hundreds wheel 720 likewise has an inner toothed ring 721 and anoutwardly protruding end cam 722.

FIGS. 16I and 16J

The counter body 740 consists of the base plate 743, the lens 742 set onthe top at right angles, the axle 741 extending perpendicularly from thebase plate 743, as well as the drive-wheel bearing 744.

FIGS. 16K and 16L

Bearing on the units wheel 701, the counter cover plate 760 is fixed onthe axle 741 of the counter body 740. The counter cover plate 760 has anelastic adjusting tongue 761 with a wedge cam 762 at the end, which cam762 moves at all times between two cams 703 of the units wheel 701.

FIGS. 16M and 16N

The star-shaped drive wheel 790 is fitted on the one hand between theunits wheel 701 and the tens wheel 780 and on the other hand between thetens wheel 780 and the hundreds wheel 720. It has six uniformly arrangedteeth 791, of which every second tooth 791 has an undercut 792 at itstip on one side of the drive wheel 790.

FIG. 16O

When a correct inhalation has been completed and the inhaler has beenclosed again by swinging the protective cap 950 upwards and pushing itin, the actuation of the counter 700 takes place. Only on pushing thedosing slide 300 back into the starting position—Situation A1—is a cam703 on the units wheel 701 gripped by the cam 306 situation on thespring leaf 305, and the units wheel 701 thereby turned by one countposition.

When the intended number of doses have been taken from the inhaler, thehundreds wheel 720 is in such a position that the end cam 722 haspositioned itself at the far top and, on pulling the carriage 500 out,the shoulder 509 (see FIGS. 7A to 7D) strikes against the end cam 722.Further actuation of the inhaler is thus blocked.

FIGS. 17A to 17C

As an option for increasing the safety of handling of the inhaler, tworotationally movable blocking hooks 140 are provided which can befastened onto the plugs 123 in the lower part 100 of the housing. Theblocking hook 140 is two-armed and is divided into a thin spring arm 142and a more solid lever 143, the spring arm 142 spreading away from thelever 143. The blocking hook 140 has a bore 146 so that the blockinghook 140 can be fastened onto the plug 123. On the lever 143 there is ablocking tooth 144 protruding out to one side and pointing away from thespring arm 142, as well as a catch 145 pointing forwards and extendingthe length of the lever 143.

FIGS. 18A to 18C

In the assembled state, the following arrangement obtains in SituationA1. The lower part 100 of the housing and the upper part 150 of thehousing are joined together. The mouthpiece 900 is inserted from thefront and the protective cap 950 is fully closed.

The slide rail 200, the carriage 500, the dosing slide 300, the shutter400 lie in the housing parts 100, 150. The valve guide 850 is fitted,and therein the valve shield 800, as well as the complete funnelarrangement—consisting of funnel 690, funnel holder 601 and funnel lid680—and the counter 700. The valve shield 800 is in its rearmostposition, and the dosing slide 300 is located such that the dosingcavity 302, positioned under the funnel outlet 608, can fill withmedicament. The closure part 401 of the shutter 400 protrudes into thechannel inlet 914. The clamping prongs 163—additionally fixing themouthpiece 900—sit in its shaft 932 and engage in the grooves 933. Thehalf-cams 912 of the mouthpiece 900, joined together, are locked in thereceiving notch 162 in the upper part 150 of the housing. The connectorplugs 911 of the mouthpiece 900 pass through the receiving notches 109in the lower part 100 of the housing, and the ramp 935 of the mouthpiece900 engages under the front edge of the roof part 210 of the slide rail200. The side arms 960 of the protective cap 950 protrude through theslots 110 in the lower part 100 of the housing and through the slots 161in the upper part 150 of the housing and embrace the wings 503, 523 ofthe carriage 500. The pins 962 now hang in the apertures 505, while thecams 504 engage in the apertures 961. To fix the protective cap 950 inthe starting position, the safety cams 125 are locked into the dimples972.

The feet 204 of the slide rail 200 engage in the depressions 124 in thelower part 100 of the housing. The angled rails 616 of the funnel holder601 are driven into the vertical grooves 167 of the U-profiles 166 onthe upper part 150 of the housing. The funnel 690 sits with its retainercams 695 and its fixing nose 696 in the notches 619 and in the groove615, respectively, of the funnel holder 601. The outlet 692 of thefunnel 690 with the sealing member 694 is situated in the funnel outlet608. In addition, the funnel holder 601 is fixed laterally by the limitcams 164 in the upper part 150 of the housing.

The complete counter 700 is held by the supports 159 in the upper part150 of the housing. The capsule 810 of the valve shield 800 sits to themaximum extent in the valve guide 850, the limit stop flange 851 of thelatter sitting in the receiving grooves 104, 156 of the lower part 100of the housing and the upper part 150 of the housing, respectively, andthe connecting web 115 coming into engagement with the notch 856.

FIGS. 19A to 19D

This sequence of figures illustrates the release of the shutter 400which surrounds the dosing cavity 302 of the dosing slide 300 filledwith medicament, upon swinging the protective cap 950 down.

FIGS. 19A and 19B

In accordance with Situation A1, the carriage 500 is so positioned thatits wings 503, 523 stand before the funnel holder 601, i.e. the pin 962of the side arm 960 of the protective cap 950, engaging in the aperture505, is ineffective as regards unlocking the unmovable shutter 400. Theblocking cams 609 under the funnel holder 601 engage behind the wings405 projecting laterally on the shutter 400. The dosing cavity 302 issituated underneath the funnel outlet 608 and could already be filledwith medicament.

FIG. 19C

The protective cap 950 has in the meantime been pulled out completelyand the carriage 500 hanging on the side arms 960 has been pulledforward; Situation A2 has been reached. The shutter 400 is stillunmovable and, with its closure part 401, surrounds the dosing cavity302 which has been pushed into the channel inlet 914 of the mouthpiece900 by means of pulling off the protective cap 950 and filled withmedicament.

The swinging-down of the protective cap 950 now commenced, i.e.situation A3 is being implemented. However, the protective cap 950 hasnot yet been sung down fully, so that the pin 962 ascends in theaperture 505 during the swinging-down movement and consequentlygradually raises and unlocks the lamella 605 arresting the shutter 400.

FIG. 19D

In situation A3 which has been reached—this also applies to SituationsA4 to A7—the protective cap 950 has been swung down fully, as a resultof which the pin 962 forces the lamella 605 up. The blocking cam 609 isthus disengaged from the wing 405 on the shutter 400. The shutter 400 ismovable, i.e. readiness for inhalation exists in conjunction withsituation A3. The swung-down protective cap 950 is fixed in thisposition by the cooperation of the safety cams 125 in the lower part 100of the housing and the dimples 971 on the side arms 960.

FIGS. 20A to 20F

This sequence of figures illustrates a complete inhalation cycle withthe mechanical events occurring in the different possible situations.

FIG. 20A

In situation A1, the valve shield 800, the carriage 500 and the shutter400 are located in their rear end position. This is the state of theinhaler after the protective cap 950 is closed following a correctlyperformed inhalation or prior to the first use. With the protective cap950 being pushed in, the shutter 400, the valve shield 800 and thedosing slide 300 have been pushed back into the rear end position by thecarriage 500. The pull catch 521 of the carriage 500 grips the carrier409 of the shutter 400. With its spring wedges 514, the carriage 500presses against the catches 321 of the dosing slide 300, the springwedges 514 being enclosed to the inside by the locking teeth 824.

The two struts 508, 510 of the carriage 500 have pushed the valve shield800 into its starting position. A cam 703 on the units wheel 701 of thecounter 700 has been put forward one unit by the cam 306 on the dosingslide 300. The dosing cavity 302 is now once again situated underneaththe funnel outlet 608.

FIG. 20B

In situation A4 the inhaler is in a state of readiness for inhalation.By pulling the protective cap 950 out, the valve shield 800 is advancedfrom the rearmost position. The carriers 821 on the tentacles 820 havebeen gripped by the wings 503, 523 and pulled forward slightly, so thatthe stubs 813 of the valve shield 800 are removed from the holes 855 ofthe valve guide 850 and create air gaps. The inhaling patient is able todraw breath through these air gaps if no other air inlets are providedon the inhaler. On pulling the protective cap 950 out, the carriage 500was moved with its grate section 515 past the grate section 621 of thefunnel holder, so that a vibration was generated for promoting the flowof the medicament powder from the funnel 690 into the dosing cavity 302.The grate sections 515, 621 are dimensioned and arranged in such a waythat when pulling the protective cap 950 out, vibrations are generatedonly so long as the dosing cavity 302 is situated under the funneloutlet 608. When the carriage 500 begins to pull the dosing slide 300with it, the grate sections 515 and 621 disengage.

The dosing slide 300 was furthermore gripped via the transverse cams 309by the pull cams 512 of the carriage 500 and moved forwards in thedirection of the mouthpiece 900 to such an extent that the dosing cavity302 is now surrounded by the closure part 401 of the shutter 400. Theshutter 400 is also released, since the blocking cams 609 underneath thefunnel holder 601 have lifted from the wings 405 of the shutter 400 asthe protective cap 950 swings down. The wedge profiles 823 of the springarms 822 of the valve shield 800 stand adjacent to the overspring ribs157 of the upper part 150 of the housing.

Pressure is exerted from above the spring arms 617 of the funnel holder601 so that all the components lying below are subjected to a certainamount of surface pressure. This increases the tightness and preventsthe escape of medicament powder. After the protective cap 950 has beenswung down, the inhaler is in a state of readiness for inhalation, andthe easier mobility of the shutter 400 is now desired. When the sidearms 960 are swung down, the surface pressure acting from above is inpart compensated, as the pin 962 ascending in the aperture 505 pressesagainst the lamellae 605. By means of the oval shape of the cam 504 andthe geometry of the aperture 961, the cam 504 has a deliberately greatervertical play in the aperture 961 than its horizontal play. The reducedsurface pressure now affords easier mobility of the shutter 400 uponinhalation.

FIG. 20C

In situation A5—the inhaler is closed again after an omittedinhalation—the valve shield 800 remained in its position, i.e. it wasnot sucked forwards. When the protective cap 950 is applied, thecarriage 500 is pushed back; its spring tongues 513 move away from thecatches 321 of the dosing slide 300. The valve shield 800 is againpushed into its rearmost position by the carriage 500; the shutter 400is locked again. The dosing slide 300 remains, however, with its filleddosing cavity 302 in its forward position; it remains there as a resultof suitable friction.

FIGS. 20D

In situation A6—inhalation was interrupted when incomplete—the valveshield 800 has not yet reached its forward position, as a result ofwhich the shutter 400 was not yet displaced, and the dose of medicamentremained enclosed. When the protective cap 950 is applied and thecarriage 500 pushed back, the dosing slide 300 remains with itsunemptied dosing cavity 302 at the front. The spring tongues 513 of thecarriage 500 strike via the spring wedges 514 against the catches 321and are thus bent inwards. In this way the spring wedges 514 strikeagainst the locking teeth 824 and thus push the valve shield 800 back,until the further pushing back of the valve shield 800 by the two struts508 and 510 of the carriage 500 takes place.

FIG. 20E

After incomplete inhalation and reclosing of the inhaler—situationA8—the filled dosing slide 300 stands forward, while the valve shield800 and carriage 500 are again situated in the rear starting position.

FIG. 20F

In situation A7—after completed inhalation—the protective cap 950 isswung fully down, as a result of which the pins 962 have lifted thelamellae 605 of the funnel holder 601 and the wings 405 of the shutter400 have been unlocked. During a correct inhalation, the valve shield800 has been sucked forwards. The spring arms 822 with the wedgeprofiles 823 have surmounted the overspring ribs 157 in the upper part150 of the housing as a result of the valve shield 800 moving forwards.The shutter 400 was pushed into its front end position by the advancingvalve shield 800, by which the means the dosing cavity 302 became freeand the medicament was inhaled by the patient.

During a correct inhalation the valve shield 800 has been suckedforwards, after its spring arms 822 with the wedge profile 823 havesurmounted the overspring ribs 157. It is possible to define thenecessary suction effort with the geometry of the wedge profile 823 andof the overspring ribs 157, and with the elasticity of the spring arms822. In the frontmost position of the valve shield 800, the two elasticspring arms 825 with the hooks 826 arranged thereon are driven behindthe hooks 122 arranged in the lower part 100 of the housing. Thisprevents the valve shield 800 from automatically sliding back.

During the reverse movement of the carriage 500, its spring wedges 514sit clamped between the catches 321 and the locking teeth 824 and cannottherefore escape. As a result, the dosing slide 300 and the valve shield800 are now pushed back into the starting position—Situation A1—by thespring wedges 514 and the struts 508, 510. In so doing, the hooks 826,122 are released from one another.

FIGS. 21A to 21C

This sequence of figures illustrates the function of the blocking hooks140 employed in the interaction with the mouthpiece 900 and the sidearms 960 of the protective cap 950.

FIG. 21A

In the starting position B1, the protective cap 950 is closed, i.e.pushed on; the mouthpiece 900 however is absent when fitting theblocking hooks 140. The spring arms 142 protrude through the apertures117 in the bars 106, support themselves therein and force the levers 143outwards. The blocking teeth 144 strike the solid side arms 960 of theprotective cap 950.

FIG. 21B

Here—in the incorrect position B2—the protective cap 950 is pulled outand swung down; the carriage 500 is pulled forward, so that the springarms 142 are pressed back into the apertures 117 by the carriage 500, asa result of which the levers 143 are under increased tensioning. Themouthpiece 900 has been removed, however, for example for a cleaningprocedure. The blocking teeth 144 now engage in the apertures 970present in the side arms 960, since the levers 143 are forced outwardsby the pressure of the spring arms 142. In this state, the protectivecap 950 cannot be swung up in order to push it in. Thus, the absence ofthe mouthpiece 900 is made evident, and this precludes a situation wherethe patient puts the inhaler away without the mouthpiece 900 beingfitted and cannot then use the inhaler in an emergency.

FIG. 21C

In the desired position B3, the mouthpiece 900 is fitted. The connectorplugs 911 of the mouthpiece 900 project into the receiving notches 109.The bevels 931 of the connector plugs 911 here press the catches 145 ofthe levers 143 inwards, counter to the tensioning of the spring arms142, so that the blocking teeth 144 are drawn out of the apertures 970.The protective cap 950 can thus be swung up again and closed.

FIGS. 22A and 22B

With correct positioning of the inhaler, i.e. when there is noover-critical inclination in the horizontal or in the axial axis ofrotation, the blocking balls 130 position themselves centrally in theball sockets 108 at the deepest points. In such a position, theprotective cap 950 can be pulled out, since the appended carriage 500 isnot blocked and can also be moved out.

If the inclination is over-critical, then the blocking balls 130 rollfrom the deepest points onto the lateral limits 116,120 and now liehigher up because of the oblique slopes in the ball sockets 108. Outwardtravel of the carriage 500 is now blocked. The blocking balls 130 nowcome into collision with the impact ridges 524 and the bulges 516, sothat ultimately the protective cap 950 cannot be pulled out. This safetymeasure guarantees that the inhaler is held in the correct position whenit is opened, so that a correct filling of the dosing cavity 302 withmedicament powder is ensured. The inhaler has to be opened in theprescribed position, but it can be used in any position once it has beenopened, that is to say, in particular, also for patients who are lyingdown. A further control on its use is afforded by the fact that theprotective cap 950 can only be swung downwards.

FIGS. 23A to 23G

This series of figures gives an impression of the successiveconstruction of the inhaler, although this need not necessarilycorrespond with the sequence of assembly in mass manufacture.

The valve guide 850 is fitted into the rear of the lower part 100 of thehousing and the valve shield 800 is fitted into the valve guide 850. Themouthpiece 900 projects from the front, only one half of the mouthpiece900 being shown for reasons of improved clarity (FIG. 23A). The inhaleris equipped with the slide rail 200 placed near the mouthpiece 900 andwith the carriage 500 bearing on the valve shield 800 (FIG. 23B). Thedosing slide 300 is now placed on the slide rail 200 (FIG. 23C). Theshutter 400 is added for further completion (FIG. 23D). The protectivecap 950 with the lateral side arms 960, which are attached to thecarriage 500, is now fitted (FIG. 23E). The completely fitted funnelarrangement 600, which is directed towards the protective cap 950, andthe counter 700 are shown here in two views (23F, 23G). Finally, theupper part 150 of the housing would have to be fitted.

Further constructional variations can be made to the inhaler which hasbeen described. The following variations are expressly mentioned here:

Instead of the dimples 972 for arresting the protective cap 950 in thepushed-in state—situation A1—an outwardly directed cam could in eachcase be provided near the entrance to the cap 952 on the upper side ofthe side arms 960 and engage in slots in the front side 160 of the upperpart 150 of the housing in the closed state. In order to detach theprotective cap 950 from the mouthpiece 900, the protective cap is to bepressed-in in the area of the lateral grip contours 951, as a result ofwhich the cams come out.

In the mouthpiece 900, near the channel outlet 922, it is possible toprovide in the enlarged channel section 928 a three-dimensionalsurface-profiled wall section with a transverse fluting in order topromote the powder deagglomeration and the deposition of coarserparticles ineffective for inhalation.

To hold the two halves of the mouthpiece 900 together, complementaryconnecting elements could be arranged in each case on the inner cutedges of the two halves—for example, a combination of bores and cams—inorder for both halves to be joined together again after possiblecleaning and drying.

To embed the funnel arrangement in the inhaler, it might be possible touse a collar made of elastic material which is pushed onto the funnelholder 601.

The pharmacological dry powder stored in the funnel 690 can be in looseform on the one hand. However, pre-dosed units for dispensing are alsoincluded, for example as an extruded pellet lane or in pearl chain form.Individually dosed units for dispensing could be arranged in blisters oron tape rolls. It will be appreciated that the medicament reservoir anda device for dividing off the individual doses are to be designed inaccordance with each other.

Irrespective of the greater outlay in terms of manufacturing technology,the above-described two-part housing, consisting of the lower part 100of the housing and the upper part 150 of the housing, could also be madein one piece.

The atomizer path 924 in the mouthpiece 900 is designed as a straight orwinding channel in which at least one baffle 925 is arranged, and thelatter can be an inwardly projecting lamella, a wall, a flow body or ascreen.

Instead of the mechanical counter 700, it is also possible to use a chipwith which all relevant data are recorded, such as number of inhalationsperformed, time of intake, and flow parameters.

The flow control realized at present means of the overspring rib 157 andthe spring arms 822 could also be obtained by means of an alterableresistance within the valve guide 850.

To regulate the flow rate, it is advantageous to provide an insert forreceiving an optional nozzle within the mouth tube 920, namely at thestat of the atomizer path 924 or mounted upstream of the mouth tube.

For specific changing of the flow resistance in the inhaler during aninhalation, which resistance is obtained by the air gap between thefixed valve guide 850 and the moving capsule 810 of the valve shield800, it is possible to configure this air gap, effective at therespective position of the valve shield 800, incrementally by means ofphysical irregularities on the surface of the capsule 810 and/or in theinside of the valve guide 850. For this purpose, consideration may begiven, for example, to widening or narrowing physical dimensions on thecapsule 810 of the valve shield 800 and in the valve guide 850 orgrooves whose cross-section changes along their length.

In the inhaler which has been described, but also in inhalers ingeneral, there is the possibility of recording the inhalations and theirflow parameters by means of sensor technology. To measure theparameters, use is made of membrane/bending beam technology or apiezoresistive element in combination with a diaphragm or in combinationwith the Venturi measurement principle. With IPC logic and sensortechnology, open-loop control becomes closed-loop control. Thisclosed-loop control makes it possible to govern an adjustable nozzle viaan electronic movement element, which nozzle finally regulates the flowin the inhaler constantly by a resistance change.

For current supply, a dynamo is provided in the inside of the inhalerand generates an electric current when the protective cap 950 is openedor when air flows through the inhaler during the inhalation, thiselectric current being stored and being used to supply the electroniccomponents.

The electronic components, as a plug-in, re-usable control module, canbe removed from the inhaler so that a battery operation is possible. Theinhalation data are collected by means of an integrated memory chip andmade available to the doctor or pharmacist. Exact monitoring of the doseadministration is thus possible. The plug-in modules can be recharged onbase units for further use and/or can be programmed so that only thecontaminated part of the inhaler is to be discarded.

To better monitor the inhalation procedure, a mechanically and/orelectronically generated acoustic and/or optical signal is emitted oncompletion of a successful or unsuccessful inhalation.

It is also possible to arrange the two complementary grate sections 515,621 on the one hand on the carriage 500 and on the other hand on thelower part 100 of the housing or on the upper part 150 of the housing.So that vibrations occur only when the protective cap 950 is beingpulled out—but not when it is being pushed back—one of the two gratesections 515, 621 can be taken out of operation on each replacement ofthe protective cap 950, e.g. on a component which is also movable.

The desiccant powder at present accommodated in the funnel lid 680inside the chamber 681 could also be positioned inside the funnel holder601.

The outer contours of the inhaler and the internal weight distributionmean that when it is laid on an essentially horizontal and dimensionallystable support, the inhaler always orients itself with the outlet 608 ofthe funnel holder 601 pointing downwards.

What is claimed is:
 1. The inhaler for multiple dosed administration ofa pharmacological dry power, comprising: a housing including a lowerpart and an upper part; a mouthpiece attached to an end of said housing,said mouthpiece including a channel extending therethrough; a protectivecap covering said mouthpiece, said protective cap being movable betweena closed position and an open position; a medicament reservoir locatedinside said housing, said medicament reservoir containing dry powder andincluding a funnel outlet; a movable shutter positioned inside saidhousing, said shutter including a closure part which protrudes into saidchannel of said mouthpiece; a movable dosing slide located inside saidhousing, said dosing slide movable between a receiving position and adispensing position, said dosing slide including a dosing cavitypositioned underneath said funnel outlet of said medicament reservoirwhen said dosing slide is in said receiving position, said dosing cavitybeing fillable with dry powder when said dosing slide is in saidreceiving position, said dosing slide moving into said dispensingposition upon moving said protective cap from said closed position tosaid open position, said dosing cavity moving into said closure part andbeing surrounded by said closure part upon movement of said dosing slideinto said dispensing position; a movable valve shield positioned insidesaid housing, said valve shield being movable between a rest positionand a forward position in response to suction generated duringinhalation, said valve shield moving said shutter when said valve shieldmoves into said forward position, the movement of said shutter releasingsaid dosing cavity from said closure part to thereby permit the releaseof dry powder from said dosing cavity into said channel of saidmouthpiece and to permit the inhalation of dry powder by a user of saidinhaler; locking means for locking said valve shield in said forwardposition only upon a defined minimum intensity of inhalation; returnmeans for returning said dosing slide to said receiving position onlyafter a correctly completed inhalation, thereby returning said dosingcavity underneath said funnel outlet; and a recording unit positionedinside said housing, said recording unit recording the number ofcorrectly performed inhalations and having a protrusion that moves froman initial position to a final position such that, when said protrusionreaches its final position, the protrusion obstructs the return meansfrom moving said dosing slide into its receiving position, therebypreventing further use of the inhaler.
 2. The inhaler according to claim1, wherein said locking means includes at least one spring arm extendingfrom said valve shield, each of said at least one spring arm having awedge profile at an end thereof; and at least one rib positioned in saidupper part of said housing, each of said at least one spring arm passingover a corresponding one of said at least one rib when the definedminimum intensity of inhalation is achieved.
 3. The inhaler according toclaim 1, wherein said return means includes a movable carriagepositioned inside said housing, said carriage including two rearwardlyprojecting spring tongues, each spring tongue having a spring wedgelocated on an end thereof; and said dosing slide, including twodownwardly directed catches located at an end of said dosing slideopposite said dosing cavity, each spring wedge pressing against acorresponding catch as said carriage is moved away from said mouthpiece,said dosing slide moving in conjunction with said carriage.
 4. Theinhaler according to claim 1, further comprising a longitudinallydisplaceable carriage positioned inside said housing, said carriageincluding two rearwardly projecting spring tongues, each spring tonguehaving a spring wedge located on an end thereof; said dosing slide,including two downwardly directed catches located at an end of saiddosing slide opposite said dosing cavity; and two side arms projectingfrom said protective cap, said side arms being connected to saidcarriage such that as said protective cap is moved from said closedposition to said open position, said carriage is pulled toward saidrnouthpiece, each spring wedge pressing against a corresponding catch assaid carriage is pulled toward said mouthpiece, such that said dosingslide is pulled toward said mouthpiece.
 5. The inhaler according toclaim 4, further comprising blocking means for blocking the movement ofsaid protective cap when said inhaler is rotated about a central axis ofsaid inhaler beyond a predetermined point.
 6. The inhaler according toclaim 5, wherein said blocking means includes at least one ball socketin said lower part of said housing; a stepped bulge and two impactridges positioned on an underside of said carriage, said bulge and saidimpact ridges corresponding to each of said at least one ball socket;and a movable blocking ball positioned in each of said at least one ballsocket, and upon rotation of said inhaler about said central axis, saidblocking ball blocks the movement of said carriage.
 7. The inhaleraccording to claim 1, wherein said medicament reservoir includes afunnel holder; a funnel positioned in said funnel holder; a funnel lidpositioned on said funnel; and a chamber located in said funnel lid, ahygroscopic desiccant powder contained in said chamber.
 8. The inhaleraccording to claim 7, wherein hygroscopic desiccant powder is containedin a space provided in said funnel holder.
 9. The inhaler according toclaim 1, wherein the suction required to move the said shutter from itsrest position to its forward position is determined by a resistancewhich said valve shield has to overcome during inhalation.
 10. Theinhaler according to claim 9, wherein said locking means creates saidresistance and said locking means includes at least one spring armextending from said valve shield, each of said at least one spring armhaving a wedge profile at an end thereof; and at least one ribpositioned in said upper part of said housing, each of said at least onespring arm passing over a corresponding one of said at least one ribwhen the defined minimum intensity of inhalation is achieved.
 11. Theinhaler according to claim 9, further comprising a valve guidesurrounding said valve shield and an obstacle to be surmounted duringmovement of said valve shield inside said valve guide. whereby saidresistance varies with the size and shape of said obstacle.
 12. Theinhaler according to claim 11, further comprising an air gap betweensaid valve guide and said valve shield, said air gap being configuredincrementally by physical irregularities in an inner surface of saidvalve guide and on an outer surface of said valve shield.
 13. Theinhaler according to claim 9, wherein said resistance is dependent uponthe distance between said rest position and said forward position ofsaid shutter, whereby said resistance varies in accordance with saiddistance.
 14. The inhaler according to claim 1, wherein said mouthpieceincludes a channel inlet; a mouth tube having a channel outlet; and anatomizer path connecting said channel inlet and said channel outlet,said atomizer path including a first channel section having at least onebaffle and a second channel section in communication with said firstchannel section, said second channel section having a larger volume thansaid first channel section, said second channel section having a wallsection with a textured surface.
 15. The inhaler according to claim 14,wherein said first channel section is straight.
 16. The inhaleraccording to claim 14, wherein said first channel section has a windingconfiguration. screen.
 17. The inhaler according to claim 14, whereinsaid mouth tube includes an end face having an upper region, saidchannel outlet being located in said upper region.
 18. The inhaleraccording to claim wherein said mouthpiece is detachable from saidhousing.
 19. The inhaler according to claim 18, said mouthpiece isconnected to said housing by a plug connection.
 20. The inhaleraccording to claim 14, wherein said mouthpiece is a multi-part componentwhich can be opened after detachment from said housing.
 21. The inhaleraccording to claim 20, wherein the parts of said mouthpiece areconnected to one another by an integral hinge.
 22. The inhaler accordingto claim 21, wherein said mouthpiece includes two symmetrical halveshaving corresponding complementary connecting elements, and wherein saidintegral hinge is located on an outer end face of said mouthpiece. 23.The inhaler according to claim 1, wherein said recording unit recordsadditional relevant data on the use of said inhaler.
 24. The inhaleraccording to claim 23, wherein said recording unit records the times andflow parameters of each use of said inhaler.
 25. The inhaler accordingto claim 1, wherein said recording unit indicates the completion of aninhalation by generating a signal.
 26. The inhaler according to claim25, wherein said signal is acoustic.
 27. The inhaler according to claim25, wherein said signal is optical.
 28. The inhaler according to claim25, wherein said signal is acoustic and optical.
 29. The inhaleraccording to claim 1, further comprising vibrating means for generatingvibrations as said protective cap is moved from said closed position tosaid open position and while said dosing cavity is positioned underneathsaid funnel outlet of said medicament reservoir.
 30. The inhaleraccording to claim 29, wherein said vibrating means includes a firstgrate section located on said lower part of said housing and a secondgrate section located on a movable carriage connected to said protectivecap.
 31. The inhaler according to claim 30, wherein said first gratesection is located on said medicament reservoir.
 32. The inhaleraccording to claim 1, further comprising first grip contours on saidprotective cap; preventing means for preventing said protective cap frombeing moved from said closed position to said open position, saidpreventing means being disengaged by pressing said protective cap in thearea of said first grip contours; two side arms attached to saidprotective cap, said side arms being constructed such that moving saidprotective cap from said closed position to said open position requiressaid protective cap to be moved along a longitudinal axis of saidinhaler before said protective cap is moved downward to said openposition, thereby ensuring that the user places said inhaler in a properoperating position; and second grip contours on an exterior of saidhousing.
 33. The inhaler according to claim 32, wherein said preventingmeans includes two safety cams located inside said housing, and a safetydimple located on each of said side arms near said protective cap, eachsafety dimple engaging a corresponding safety cam, thereby preventingmovement of said protective cap.
 34. The inhaleraccording to claim 32,wherein said second grip contours are grip dimples.
 35. The inhaleraccording to claim 1, further comprising positioning means forpositioning said protective cap in said open position.
 36. The inhaleraccording to claim 35, wherein said positioning means includes twosafety cams located inside said housing; and two side arms attached tosaid protective cap, each side arm including a locking dimple locatedopposite said protective cap, each locking dimple engaging acorresponding safety cam, thereby securing said protective cap in saidopen position.
 37. The inhaler according to claim 1, further comprisingprohibiting means for prohibiting said inhaler from being closed bymoving said protective cap from said open position to said closedposition when said mouthpiece has been removed from said inhaler. 38.The inhaler according to claim 37, wherein said prohibiting meansincludes at least one blocking hook positioned in said housing, each ofsaid at least one blocking hook locking said protective cap in said openposition when said mouthpiece is removed, each of said at least oneblocking hook unlocking said protective cap from said open position uponinsertion of said mouthpiece.
 39. The inhaler according to claim 1,further comprising a valve guide having a bottom with a plurality ofholes; and said valve shield, including a bottom with a plurality ofstubs corresponding to said holes, said stubs engaging in said holes.40. The inhaler according to claim 1, wherein said dosing cavity is anopening passing through said dosing slide; and a slide rail ispositioned underneath said dosing slide, said slide rail extending alongthe length of said dosing cavity, thereby closing said dosing cavityfrom below when said dosing cavity is positioned underneath said funneloutlet of said medicament reservoir.